Clinical Infectious Diseases

MAJOR ARTICLE

Epidemiology of Acute Myocarditis/Pericarditis in Hong

Kong Adolescents Following Comirnaty Vaccination
Gilbert T. Chua,1,2,a, Mike Yat Wah Kwan,3,a Celine S. L. Chui,4,5,6 Robert David Smith,4 Edmund Chi-Lok Cheung,7 Tian Ma,6 Miriam T. Y. Leung,6,7
Sabrina Siu Ling Tsao,1,2 Elaine Kan,8 Wing Kei Carol Ng,8 Victor Chi Man Chan,9 Shuk Mui Tai,9 Tak Ching Yu,9 Kwok Piu Lee,9 Joshua Sung Chih Wong,3
Ying Kit Lin,3 Chi Chiu Shek,3 Agnes Sze Yin Leung,10 Chit Kwong Chow,11 Ka Wah Li,12 Johnny Ma,13,14,15,16 Wai Yuk Fung,13,14,15,16 Daniel Lee,17
Ming Yen Ng,18,19 Wilfred Hing Sang Wong,1 Hing Wai Tsang,1 Janette Kwok,20 Daniel Leung,1 Kin Lai Chung,21 Chun Bong Chow,1 Godfrey Chi Fung Chan,1,2

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Wing Hang Leung,1,2 Kelvin Kai Wang To,22, Kwok Yung Yuen,22 Yu Lung Lau,1,2 Ian Chi Kei Wong,6,7,23 and Patrick Ip1
1
Department of Pediatrics and Adolescent Medicine, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong SAR, China; 2Department of Paediatrics, Hong Kong Children’s
Hospital, Hong Kong SAR, China; 3Department of Pediatrics and Adolescent Medicine, Princess Margaret Hospital, Hong Kong SAR, China; 4School of Nursing, The University of Hong Kong, Hong
Kong SAR, China; 5School of Public Health, The University of Hong Kong, Hong Kong SAR, China; 6Laboratory of Data Discovery for Health (D24H), Hong Kong Science and Technology Park, Hong
Kong SAR, China; 7Centre for Safe Medication Practice and Research, Department of Pharmacology and Pharmacy, The University of Hong Kong, Hong Kong SAR, China; 8Department of Radiology,
Hong Kong Children’s Hospital, Hong Kong SAR, China; 9Department of Paediatrics and Adolescent Medicine, Pamela Youde Nethersole Eastern Hospital, Hong Kong SAR, China; 10Department of
Pediatrics, Prince of Wales Hospital, The Chinese University of Hong Kong, Hong Kong SAR, China; 11Department of Pediatrics and Adolescent Medicine, United Christian Hospital, Hong Kong SAR,
China; 12Department of Pediatrics and Adolescent Medicine, Tuen Mun Hospital, Hong Kong SAR, China; 13Department of Radiology, Caritas Medical Centre, Hong Kong SAR, China; 14Department
of Radiology, North Landau Hospital, Hong Kong SAR, China; 15Department of Radiology, Princess Margaret Hospital, Hong Kong SAR, China; 16Department of Radiology, Yan Chai Hospital, Hong
Kong SAR, China; 17Department of Radiology, Pamela Youde Nethersole Eastern Hospital, Hong Kong SAR, China; 18Department of Diagnostic Radiology, The University of Hong Kong, China;
19
Department of Medical Imaging, The University of Hong Kong-Shenzhen Hospital, China; 20Division of Transplantation and Immunogenetics, Department of Pathology, Queen Mary Hospital, Hong
Kong SAR, China; 21Quality and Safety Division, Hospital Authority Head office, Hong Kong SAR, China; 22Department of Microbiology, Carol Yu Centre for Infection, Li Ka Shing Faculty of Medicine,
The University of Hong Kong, Hong Kong SAR, China; and 23Research Department of Practice and Policy, UCL School of Pharmacy, University College, London, United Kingdom

Background.  Age-specific incidence of acute myocarditis/pericarditis in adolescents following Comirnaty vaccination in Asia
is lacking. This study aimed to study the clinical characteristics and incidence of acute myocarditis/pericarditis among Hong Kong
adolescents following Comirnaty vaccination.
Methods.  This is a population cohort study in Hong Kong that monitored adverse events following immunization through a
pharmacovigilance system for coronavirus disease 2019 (COVID-19) vaccines. All adolescents aged between 12 and 17 years following
Comirnaty vaccination were monitored under the COVID-19 vaccine adverse event response and evaluation program. The clinical
characteristics and overall incidence of acute myocarditis/pericarditis in adolescents following Comirnaty vaccination were analyzed.
Results.  Between 14 June 2021 and 4 September 2021, 33 Chinese adolescents who developed acute myocarditis/pericarditis fol-
lowing Comirnaty vaccination were identified. In total, 29 (87.88%) were male and 4 (12.12%) were female, with a median age of 15.25
years. And 27 (81.82%) and 6 (18.18%) cases developed acute myocarditis/pericarditis after receiving the second and first dose, respec-
tively. All cases are mild and required only conservative management. The overall incidence of acute myocarditis/pericarditis was 18.52
(95% confidence interval [CI], 11.67–29.01) per 100 000 persons vaccinated. The incidence after the first and second doses were 3.37
(95% CI, 1.12–9.51) and 21.22 (95% CI, 13.78–32.28 per 100 000 persons vaccinated, respectively. Among male adolescents, the inci-
dence after the first and second doses were 5.57 (95% CI, 2.38–12.53) and 37.32 (95% CI, 26.98–51.25) per 100 000 persons vaccinated.
Conclusions.  There is a significant increase in the risk of acute myocarditis/pericarditis following Comirnaty vaccination among
Chinese male adolescents, especially after the second dose.
Keywords.  myocarditis; pericarditis; adolescents; Comirnaty; Hong Kong.

The coronavirus disease 2019 (COVID-19) infection in children
is generally mild, but serious complications, such as pediatric
multisystem inflammatory syndrome—temporally associated
Received 25 September 2021; editorial decision 21 November 2021; published online
28 November 2021.
a
G. T. C. and M. Y. W. K. contributed equally to this work.
Correspondence: P. Ip, Clinical Associate Professor, Department of Pediatrics and Adolescent
Medicine, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong SAR, China
(patricip@hku.hk).
Clinical Infectious Diseases®  2022;XX(XX):1–9
© The Author(s) 2021. Published by Oxford University Press for the Infectious Diseases Society
of America. This is an Open Access article distributed under the terms of the Creative Commons
Attribution-NonCommercial-NoDerivs licence (https://creativecommons.org/licenses/
by-nc-nd/4.0/), which permits non-commercial reproduction and distribution of the work, in any
medium, provided the original work is not altered or transformed in any way, and that the
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https://doi.org/10.1093/cid/ciab989
with severe acute respiratory syndrome coronavirus 2 (SARS-
CoV-2) (PIMS-TS), can occur [1]. Prolonged social distancing
policies have also led to significant psychosocial impacts on
children and their families in the community [2]. Enormous ef-
forts have been made to control the spread of the virus through
universal vaccination to achieve herd immunity to return us to
a semblance of normality.
Currently, the vaccination program of the Hong Kong
Government has authorized 2 COVID-19 vaccines: the
CoronaVac from Sinovac Biotech (Hong Kong) Limited and
Comirnaty vaccine (BNT162b2) from Fosun-BioNTech.
On 14 June 2021, the government of the Hong Kong Special
Administrative Region (HKSAR) commenced vaccination of
the Comirnaty vaccine (BNT162b2) from Fosun-BioNTech

Post-Comirnaty Carditis in Adolescents • CID 2022:XX (XX XX) • 1

to adolescents by lowering of the age limit from 16 to 12 years
after reviewing the available evidence by the advisory panel on
COVID-19 Vaccines of the Food and Health Bureau, HKSAR
Government [3]. The drug office of the Department of Health
(DH), the drug regulatory authority in Hong Kong, has imple-
mented a pharmacovigilance system for COVID-19 vaccines
that monitors reports of adverse events following immuniza-
tion (AEFI). The COVID-19 vaccine Adverse event Response
and Evaluation (CARE) program was set up, an active surveil-
lance system, to evaluate AEFI data from the general population
using electronic medical records from Hospital Authority and
vaccination records from the DH. The CARE program actively
identifies AEFI and conduct epidemiological study to evaluate
the association between vaccinations and subsequent adverse
event [4, 5].
The Comirnaty is a messenger RNA (mRNA) vaccine that is
highly effective in preventing hospitalizations and deaths due
to COVID-19 [6]. Although Comirnaty has a favorable safety
profile, various regulatory agencies have advocated continuous
monitoring of its safety, as rare and long-term adverse reac-
tions might not have been detected in the clinical trials and
early post-marketing reports [7]. Recently, there have been
emerging case reports of acute myocarditis following mRNA
COVID-19 vaccination in healthy young adolescent and adult
males [8–10]. The United Kingdom has only approved offering
1 dose of the Pfizer-BioNTech vaccine to healthy adolescents
aged 12–15 years old so far, instead of giving the recommended
2 doses [11]. Yet an in-depth population-based investigation
of the age-specific incidence of acute myocarditis/pericarditis
following mRNA COVID-19 vaccination in Asian adolescents
is lacking. This study aims to report the clinical characteristics
and estimate the incidence of acute myocarditis following vacci-
nation with Comirnaty in adolescents in Hong Kong.
METHODS
This was a population cohort study aimed at identifying all sus-
pected cases of acute myocarditis in adolescents aged between
12 and 17 years who received the Comirnaty vaccine between
14 June 2021 and 4 September 2021. All individuals receiving
the Comirnaty vaccine have also consented to their vaccina-
tion records being linked to their corresponding comprehen-
sive electronic health records held by the Hospital Authority
(HA), the major publicly funded healthcare provider, through
the CARE program [4]. All suspected cases of acute myocar-
ditis/pericarditis that occur within 14 days after receiving either
the first or the second dose of the Comirnaty vaccine and ad-
mitted to one of the HA hospitals are reported to the Advanced
Incident Reporting System (AIRS) on admission, a system for
HA to report adverse drug events and AEFI to DH.
Suspected cases of acute myocarditis/pericarditis who re-
ceived Comirnaty vaccines during the study period were
2 • CID 2022:XX (XX XX) • Chua et al
investigated according to the Hong Kong Pediatric Investigation
Protocol for Comirnaty-related Myocarditis/Pericarditis
(Supplementary file 1), which was implemented in all HA hos-
pitals. Demographics including date of birth, sex, ethnicity,
date of receiving the first and the second dose of COVID-19
vaccines, symptoms, date of onset, and past medical histories
were reviewed. Microbiological investigations including naso-
pharyngeal swab (NPS) for SARS-CoV-2 and common respi-
ratory viruses including influenza A/B/C, parainfluenza virus
1/2/3/4, adenovirus, human metapneumovirus, and respiratory
syncytial virus, and throat and rectal swabs for enteroviruses
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were tested. SARS-CoV-2 anti-receptor binding domain (RBD)
and anti-nucleocapsid protein (NP) antibodies were tested to
differentiate whether the patients had a history of COVID-19
infection. Cardiac enzymes, including high-sensitivity tro-
ponin I (hsTnI), high-sensitivity troponin T (hsTnT or TnT),
electrocardiogram (ECG), and echocardiogram were serially
monitored. ECGs were interpreted by 1 single investigator (S.
S. T.). Echocardiograms were performed and interpreted by the
cardiologists of each admitting hospital. Cardiac magnetic res-
onance imaging (cMRI) was performed within two weeks of
symptoms onset either at the admission hospital, or referred to
the Hong Kong Children’s Hospital if no slots were immediately
available. The cMRI images were interpreted by the radiologists
of each magnetic resonance imaging (MRI) unit. The study
team followed the myocarditis and pericarditis case definitions
created by the Cardiovascular Injury-Coalition for Epidemic
Preparedness Innovations (CEPI) and the Brighton Working
Group [12].
Estimation of Incidence and Statistical Analysis
Vaccination records within the study period were extracted
from the DH in Hong Kong since the commencement of mass
COVID-19 vaccinations in adolescents aged 12–17 years on 14
June 2021 to 4 September 2021. The cutoff date for follow-up
time was 18 September 2021, allowing for all participants to
have a 14-day follow-up period. De-identified electronic health
records were retrieved from the HA Clinical Data Analysis and
Reporting System (CDARS), which has been successfully used
in a previous COVID-19 vaccine-related pharmacovigilance
study [4]. Subjects with a history of primary myocarditis/peri-
carditis prior to the study period were excluded. Cases of acute
myocarditis/pericarditis following Comirnaty vaccination were
identified if they occurred within 14 days of either the first or
the second vaccine dose. We estimated the background rate of
acute myocarditis/pericarditis, cases of the first primary diag-
nosis were extracted from CDARS from 2011 to 2020 using data
available from 14 June to 4 September of each year. For each
year, those with a history of acute myocarditis/pericarditis in
the prior year to the study period were censored.
Separated cases related to the first dose or to the second dose
were also calculated. Acute myocarditis/pericarditis related to
the first dose was defined as the first cases within 14 days of the
first dose. Acute myocarditis/pericarditis related to the second
dose was defined as the first cases within 14 days of the second
dose. The 14 days was the upper end of the reporting of my-
ocarditis/pericarditis cases following vaccination according to
the DH and HA reporting policies. The incidence of clinically
confirmed myocarditis/pericarditis per 100 000 doses adminis-
tered as well as number of cases per 100 000 doses for first dose
and second dose were estimated. We calculated 95% confidence
intervals (CI) for all incidences calculated using Poisson dis-
tribution. The incidence rate of acute myocarditis/pericarditis
associated with the Comirnaty vaccine was compared with the
background incidence rate of acute myocarditis/pericarditis in
2020 using 100 000 doses per 14-days. Sensitivity analyses were
conducted using (1) the background incidence rate in 2018 and
2019 and the average background incidence rate from 2011 to
2020 using 100 000 doses per 14 days and (2) changed the in-
cidence using doses per 28 days. Subgroup analysis was con-
ducted by sex. Some comparisons to background years were not
possible as there were zero cases of myocarditis/pericarditis re-
corded in background years. Median and interquartile ranges
(IQR) were used to describe skewed data. All statistical tests
were 2-sided, and P-values at a level of 5% were considered sta-
tistically significant. Statistical analyses were conducted using R
version 4.0.3 (www.R-project.org). For quality assurance, 2 in-
vestigators (E. C. C. and R. D. S.) independently conducted the
statistical analyses.
Ethical Approval
This study was approved by the Institutional Review Board of
the University of Hong Kong/Hospital Authority Hong Kong
West Cluster (UW21-149 and UW21-138) and the Department
of Health Ethics Committee (LM21/2021).
RESULTS
Between 14 June and 4 September 2021, a total of 33 cases of
myocarditis/pericarditis within 14 days following vaccination
with Comirnaty were identified. Twenty-five (75.76%) were
definite, 7 (21.21%) were probable, and 1 (3.03%) were pos-
sible cases (Table 1). The patients were all Chinese adolescents
with no history of cardiac diseases; 29 (87.88%) were male and
4 (12.12%) were female, with a median age of 15.25 years. In
total, 27 (81.82%) and 6 (18.18%) cases developed acute myo-
carditis/pericarditis after receiving the second and first dose,
respectively. These patients developed myocarditis/pericar-
ditis at a median of 2 days after receiving the last dose of the
vaccine. All of them presented with chest pain. Three cases
(9.09%) had normal troponin levels, 2 of them were cases
of definite pericarditis and 1 had possible myocarditis. Six
(18.18%) had normal ECGs, 25 (75.76%) had normal echo-
cardiograms, and 7 (21.88%) had normal cMRI. None had
significant arrhythmias. All patients had no identifiable infec-
tions. They also had no current and past history of COVID-19
infection, as evidenced by a negative SARS-CoV-2 PCR on ad-
mission and the absent of anti-SARS-CoV-2 NP antibodies in
their serum. All patients had mild diseases requiring no treat-
ment or symptomatic relief by nonsteroidal anti-inflamma-
tory drugs (NSAIDs). They spontaneously recovered without
the need of systemic steroids, intravenous immunoglobulins,
or inotropic or circulatory support.
There have been 305 406 doses of Comirnaty vaccine ad-
ministered to 178 163 individuals aged 12–17 years (88 357
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[49.59%] are female) since the commencement of the vac-
cination program on 14 June 2021 until 4 September 2021.
This represented 51.84% of the population between 12 and
17 years (178 163/343 700) in Hong Kong in mid-2021 [13].
The overall incidence for acute myocarditis/pericarditis was
18.52 (95% CI, 11.67–29.09) per 100  000 persons. The in-
cidence after the first and second doses were 3.37 (95% CI,
1.12–9.51) and 21.22 (95% CI, 13.78–32.28) per 100 000 per-
sons vaccinated, respectively (Table 2). Incidence was higher
among male adolescents compared to females (Table 2).
Incidence rates compared with previous years’ background
rates are shown in Table 2 and Supplementary Tables 1–3.
Compared to the background incidence rate of acute myo-
carditis/pericarditis in 2020 there were significantly higher
incidence rate differences in those vaccinated (Table 2).
Sensitivity analyses using the background incidence rate in
2018, 2019, and 2020 and the average background incidence
rate from 2011 to 2020 using per 100  000 per 28-days also
demonstrated significantly higher incidence rate differences
in those vaccinated which was consistent with the main re-
sults (Supplementary Tables 4–8).
Among males after their first dose, there was a significantly
higher incidence rate difference compared the background rate
in 2020. After the second dose there was significantly higher
incidence rate difference between the background rate in 2020
and all participants and males (Table 3).
DISCUSSION
To our best knowledge, this is the first study in adolescents
using data from the territory-wide post-COVID-19 vaccina-
tion monitoring system to analyze the incidence of acute myo-
carditis/pericarditis associated with the Comirnaty vaccine for
adolescents in Asia.
Our analysis revealed that the overall incidence of
acute myocarditis/pericarditis in adolescent following the
Comirnaty vaccination was 18.52 per 100  000 persons vac-
cinated. Majority cases involved healthy adolescent males
after receiving the second dose. No other infective causes in-
cluding SARS-CoV-2 infection were identified. Conservative
management with NSAIDs was sufficient. This higher
Post-Comirnaty Carditis in Adolescents • CID 2022:XX (XX XX) • 3
 Table 1.  Clinical Characteristics of Adolescents With Myocarditis/Pericarditis Following Comirnaty Vaccination in Hong Kong

Present No. of Days Peak Troponin

Sex/Age at After First After Levels(hsTnT/ Final Diagnosis
Presentation or Second Receiving the hsTnI/TnT) (Level of
No. (years) Dose Last Dose Symptoms (ng/L)b Most Significant ECG Changes ECHO MRI Findings Certaintya)

1 M/15.66 Second 2 Chest pain, headache TnT 793 STE in II, III, aVF, V3-V5 Normal Patchy edema; diffuse EGE; patchy pericar- Perimyocarditis
hsTnI 2506 dial and subepicardial LGE; normal ECV (Definite)
(elevated)
2 M/14.52 Second 1 Chest pain, fever TnT 646 TWI and biphasic T waves in III, Normal Borderline LV function; elevated T1 and Myocarditis
hsTnI 6342 aVF, V4-V6 T2 mapping values and ECV; presence (Definite)
(elevated) of LGE
3 M/13.53 Second 2 Dizziness, SOB, chest TnT 1749 (ele- STE in V2-V6TWI in aVL; bi- Normal Elevated T1 and T2 mapping values and Perimyocarditis

4 • CID 2022:XX (XX XX) • Chua et al
pain vated) phasic Ts in V3–V4 ECV; pericardium and subepicardial mus- (Definite)
cles LGE and T2 hyperintensity
4 M/13.05 First 2 Chest pain TnT 302 STE in V3–V6; TWI in III; STD Normal Elevated T1 and T2 mapping values and Perimyocarditis
(elevated) in aVR ECV; pericardial LGE extending to (Definite)
subepicardial region
5 M/14.34 Second 1 Chest pain TnT 993 STE in V3–V5; TWI in I, aVL; Normal Borderline LV function; subepicardial LGE; Perimyocarditis
(elevated) biphasic T waves in V3–V6 elevated T1 and T2 mapping values and (Definite)
ECV; hyperintense pericardium
6 M/16.99 Second 3 Chest pain TnT 948 (ele- STE in V2–V6 Mildly impaired LV Borderline LV function, small pericardial ef- Perimyocarditis
vated) global longitudinal fusion; elevated ECV, T1 and T2 mapping (Definite)
strain values; patchy LGE
7 M/15.22 Second 2 Chest pain hsTnI 11415 Normal Normal Elevated T1 and T2 mapping values; Myocarditis
(elevated) presence of patchy EGE; normal ECV; (Definite)
subepicardial LGE
8 M/15.32 Second 2 Chest pain, fever hsTnI 16806 STD and TWI in V1–2; STE in Borderline LV func- Mild increase STIR signal; faint patchy LGE; Perimyocarditis
(elevated) lead II, III, aVF; ST/T wave ab- tion (LVFS 28%), trace pericardial effusion (Definite)
normality in II, III, aVF, V4–V6 minimal pericardial
effusion
9 M/17.14 First 1 Chest pain hsTnI 19110 STE in II, III, aVF, V4–V6 Tiny rim of pericardial Elevated T1 and T2 mapping values and Perimyocarditis
(elevated) effusion ECV; no definite EGE; LGE present; (Definite)
patchy pericardial enhancement
10 F/14.07 Second 3 Chest discomfort, tran- hsTnI 54.9 STE in V4–V5 Normal Elevated T1 and T2 mapping values and Perimyocarditis
sient SOB (elevated) ECV; LGE and pericardial enhancement (Definite)
11 M/13.75 Second 2 Chest pain, palpitation, hsTnI 6254 Sinus tach; STE in II, III, aVF, Normal Elevated T1 and T2 mapping values and Myocarditis
fever (elevated) V3–V5 ECV; presence of LGE (Definite)
12 M/12.74 Second 1 Chest pain, palpita- hsTnI 14766 STD in aVR and V1; STE I-III, Thin rim of peri- Elevated T1 mapping value; presence of Perimyocarditis
tions, dizziness (elevated) aVF, V4–V6 cardial effusion, myocardial edema with increased T2W (Definite)
hyperechoic peri- signal
cardium
13 F/12.97 Second 1 Chest pain, fever, head- hsTnI 2309 Normal Normal Elevated T1 and T2 mapping values and Perimyocarditis
ache, palpitations, (elevated) ECV; pericardial and subepicardial LGE; (Definite)
subjective SOB small pericardial effusion
14 M/17.85 Second 3 Chest pain hsTnI 30267 STE in I, II, aVF, V4–V6, STD in Borderline contractility Elevated T1 and T2 mapping values and Perimyocarditis
(elevated) aVR, V1-V2; TWI in III; ECV; subepicardial and mid-wall LGE; (Definite)
biphasic Ts in V3–V5 small pericardial effusion

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 Table 1. Continued

Present No. of Days Peak Troponin

Sex/Age at After First After Levels(hsTnT/ Final Diagnosis
Presentation or Second Receiving the hsTnI/TnT) (Level of
No. (years) Dose Last Dose Symptoms (ng/L)b Most Significant ECG Changes ECHO MRI Findings Certaintya)
15 M/14.99 Second 1 Fever, chest pain, TnT 323 (ele- STE in V3-5TWI in aVR and V1 Normal T2W hyperintensity within myocardium; Perimyocarditis
palpitation, SOB, vated) regional LGE; 5mm pericardial effusion (Definite)
dizziness
16 M/16.88 Second 4 Chest pain, SOB hsTnT < 14 STE in V2 and V4 Increased Not done Pericarditis
(normal) echogenicity over (Definite)
LV free wall
17 M/17.33 Second 2 Chest pain, fever, pal- hsTnI 767 STE in II, III, aVF, V3–V6 Normal T2W hyperintense myocardial edema at Myocarditis
pitation (elevated) mid and apex of LV (Definite)
18 M/14.25 First 3 Chest pain, fever hsTnI 184 STD in II, III, aVF Normal T2W hyperintense myocardial edema at Myocarditis
(elevated) basal lateral and basal septal segments (Definite)
of LV
19 M/15.95 Second 2 Chest discomfort, pal- hsTnI 3561 STE in II, aVF, V4-V6 Normal T2W hyperintense myocardial edema Myocarditis
pitation (elevated) with LGE at apical lateral segment and (Definite)
subepicardial region
20 M/14.17 Second 2 Chest pain TnT 1058 (ele- STE in V4–V6; TWI in III, aVF Normal Mild T2W hyperintense signals and in- Myocarditis
vated) creased T2 mapping value at inferolateral (Definite)
LV wall
21 M/15.70 Second 2 Chest pain hsTnI 263 STE II, III, aVF, V4–V6 Normal Mild subepicardial basal to mid-ventricular Myocarditis
(elevated) lateral wall LGE and elevated T1 mapping (Definite)
value
22 M/15.65 Second 1 Chest pain, palpitations hsTnI 2210 STE V2–V6 Normal Generalized myocardial hyperintensity in Perimyocarditis
TnT 283 TIRM sequence; presence of hyperemia; (Definite)
(elevated) subepicardial LGE; small pericardial
effusion
23 F/16.89 First 2 Palpitation, near hsTnT 30 (el- Normal Normal LV myocardium diffuse increased T2 signal; Myocarditis
syncope, nausea, evated) patchy early Gd enhancement (Definite)
vomiting
24 M/16.88 Second 2 Chest pain, headache, TnT 669 Normal Borderline LV Normal Myocarditis
dizziness (elevated) function(LVFS (Definite)
29.1%)
25 M/14.78 Second 2 Chest pain, palpitation hsTnT < 14 STE in I,II, V2–V6, and STD in Prominent pericardial Normal Pericarditis
(normal) aVR echogenicity (Definite)
26 M/14.18 First 2 Chest pain hsTnI 513 Normal Normal Equivocal myocardial edema due to motion Myocarditis
(elevated) artefacts (Probable)
27 F/15.25 Second 6 Chest pain hsTnI 77 STE V2–V3; biphasic Ts in V3 Normal Normal Myocarditis
(elevated) (Probable)
28 M/14.31 Second 14 Chest discomfort, hsTnI 201 TWI and ST depression in II, III, Normal Normal Myocarditis
transient SOB, head- (elevated) aVF; biphasic Ts in V3–V5 (Probable)
ache, dizziness
29 M/17.87 First 2 Chest pain hsTnI 29.2 STE in II, V3–V6 Normal Normal Myocarditis
(elevated) (Probable)
30 M/17.64 Second 2 Chest pain, fever, hsTnI 4874 STE in V2–V6, TWI in aVF/III; Normal Normal Myocarditis
headache (elevated) biphasic Ts in II, aVF, V4–V6 (Probable)

Post-Comirnaty Carditis in Adolescents • CID 2022:XX (XX XX) • 5

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 Table 1. Continued

6 • CID 2022:XX (XX XX) • Chua et al
Present No. of Days Peak Troponin
Sex/Age at After First After Levels(hsTnT/ Final Diagnosis
Presentation or Second Receiving the hsTnI/TnT) (Level of
No. (years) Dose Last Dose Symptoms (ng/L)b Most Significant ECG Changes ECHO MRI Findings Certaintya)
31 M/12.85 Second 2 Chest pain, vomiting, hsTnT 39 Sinus tachycardia; STE in II, III, Normal Global hyperintensity in myocardium in Myocarditis
SOB aVF; V2–V6 T2W images with hyperintensity in early (Probable)
post-Gd images but no LGE. Suspicious
of myocarditis
32 M/15.79 Second 10 Chest pain, dizziness, hsTnT 25 Normal Normal Normal Myocarditis
near syncope (elevated) (Probable)
33 M/16.76 Second 2 Fever, chest discomfort, hsTnT < 14 STE in V2–V6 Normal Normal Myocarditis
palpitation, transient (normal) (Possible—ele-
SOB vated CRP)
34c M/15.07 Second 25 Chest pain TnT 269 STE in V2–V6 Mild pericardial Not done Perimyocarditis
hsTnI 3850 and LV free wall (Definite)
echogenicity
35c F/12.78 Second 26 Vomiting, palpitation, hsTnI 566 STE in II, V2–V5; STD in aVR; Hyperechoic pericar- Elevated T1 mapping values; subepicardial Perimyocarditis
reduced exercise TWI in aVL; Q waves in I dium LGE (Definite)
tolerance and aVL
Abbreviations: CRP, C reactive protein; ECG, electrocardiogram; ECHO, echocardiogram; ECV, extracellular volume; EGE, early gadolinium enhancement; Gd, gadolinium; hsTnI, high-sensitivity troponin I; hsTnT, high-sensitivity troponin T; LGE, late gadolinium
enhancement; LV, left ventricle; LVFS, left ventricle fractional shortening; MRI, magnetic resonance imaging; SOB, shortness of breath; STD, ST depression; STE, ST elevation; STIR, short tau inversion recovery; T2W, T2-weighted; TWI, T wave inversion;
TnT, troponin T.
a
Brighton Collaboration Myocarditis Case Definition Level of Certainty (LOC) Classification.
b
Elevated troponin level based on reference values provided by each laboratory. Subjects with two different troponin measures were because of transferal to another hospital.
c
Cases 34 and 35 presented > 14 days after receiving the second doses, therefore they were only included in the sensitivity analyses (Supplementary Tables 4–8).

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Table 2.  Incidence Rate Differences of Myocarditis/Pericarditis Cases Following Comirnaty Vaccination Stratified by Sex and Compared to Background
Rate in 2020

Incidence Rate (per 100 000 Background Incidence Rate in 2020a Incidence Rate Difference (per
person-14 days, 95% CI) (per 100 000 person-14 days, 95% CI) 100 000 person-14 days, 95% CI)

Comirnaty
 Total 18.52 (11.67–29.01) 0.11 (.01–20.36) 18.41 (9.95–26.87)
 Male 32.29 (22.78–45.4) 0.21 (.01–10.34) 32.08 (20.91–43.25)
 Female 4.53 (1.76–11.11) 0 -
Values in bold represent a statistically significant difference (P < .05).
Abbreviation: CI, confidence interval.
a
The background incidence rates were calculated using the reporting period (14 June to 4 September) in 2020 and truncated to incidence rate per 14 days.

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incidence of myocarditis/pericarditis following Comirnaty
vaccination than other jurisdictions is likely related to the
heightened vigilance of healthcare professionals and the
public [14], as well as the highly efficient CARE program
for the monitoring and reporting of AEFI across Hong
Kong [10]. Our pharmacovigilance system was able to cap-
ture mild cases of acute myocarditis/pericarditis and reveal
the real-world incidence of acute myocarditis/pericarditis
following the Comirnaty vaccination. Because the Pfizer-
BioNTech vaccine was approved for large-scale immuniza-
tion in many countries, there has been a higher observed
risk of acute myocarditis/pericarditis among younger males
receiving this vaccine [15]. The first reports in Israel were of 5
young males who developed mild myocarditis following vac-
cination with the BioNTech mRNA COVID-19 vaccine [16].
Subsequently, 23 US military males reported developing my-
ocarditis after administering more than 2.8 million doses of
either the Moderna or BioNTech mRNA COVID-19 vaccines
to military personnel [9]. In children, so far, only 1 case se-
ries reported myocarditis following vaccinations with mRNA
COVID-19 vaccines. These 7 cases were males aged 14–19
years who presented with transient mild symptoms, elevated
troponin, and MRI changes suggestive of acute myocarditis
or perimyocarditis. They were treated with NSAIDs, ster-
oids, or intravenous immunoglobulin [8]. So far, all adults
and adolescents with myocarditis/pericarditis following
COVID-19 vaccinations, including those reported in the cur-
rent study, have been mild cases [17]. However, the patho-
physiology of acute myocarditis/pericarditis following the
mRNA COVID-19 vaccine is still unclear, and the observa-
tion that only mRNA-based COVID-19 vaccines are associ-
ated with acute myocarditis remains unexplained. The causal
association between mRNA vaccine and myopericarditis has
recently been suggested in a mouse model. Higher systemic
levels of mRNA lipid nanoparticles due to inadvertent intra-
venous injection or rapid return from the lymphatic circula-
tion was proposed to increase this risk [18]. Further studies
to delineate the pathophysiology of acute myocarditis/peri-
carditis associated with mRNA-based COVID-19 vaccines is
urgently needed.
The US Center for Disease Control and Prevention
(CDC) reported that the expected rates of myocarditis/per-
icarditis following the Comirnaty vaccination would be the
highest among males aged between 12 and 29 years old,
estimating 40.6 per million second doses administered [10].
The incidence rate of myocarditis/pericarditis following the
Comirnaty vaccination in Hong Kong was much higher than
those reported from the United States [10, 19]. However,
it is important to note that the risk of myocardial injury
in healthy young individuals including athletes following

Table 3.  Incidence Rate Differences of Myocarditis/Pericarditis Cases Following the First and Second Doses of Comirnaty Vaccination Stratified by Sex
and Compared to Background Rate in 2020

Incidence Rate (per 100,000 Background Incidence Rate in 2020a Incidence Rate Difference
person-14 days, 95% CI) (per 100 000 person-14 days, 95% CI) (per 100 000 person-14 days, 95% CI)

First dose of Comirnaty

 Total 3.37 (1.12–9.51) 0.11 (.01–20.36) 3.26 (−0.40 to 6.92)
 Male 5.57 (2.38–12.53) 0.21 (.01-–10.34) 5.36 (0.65–10.07)
 Females 1.13 (0.16–6.58) 0 -
Second dose of Comirnaty
 Total 21.22 (13.78–32.28) 0.11 (.01–20.36) 21.11 (12.06–30.16)
 Male 37.32 (26.98–51.25) 0.21 (.01–10.34) 37.11 (25.10–49.12)
 Female 4.77 (1.90–11.44) 0 -
Values in bold represent a statistically significant difference (P < .05).
Abbreviation: CI, confidence interval.
a
The background incidence rates were calculated using the reporting period (14 June to 4 September) in 2020 and truncated to incidence rate per 14 days.

Post-Comirnaty Carditis in Adolescents • CID 2022:XX (XX XX) • 7

COVID-19 infection is also considerably high [20], ranging
from asymptomatic cases with abnormal cMRI only to ful-
minant myocarditis due to COVID-19 [21, 22]. Preliminary
data in Israel demonstrated a 51% effectiveness after receiving
1 dose Pfizer-BioNTech vaccine among older adults [23]. As
there have been essentially no local transmission of SARS-
CoV-2 in Hong Kong since May 2021 [24], balancing the risk
of acute myocarditis/pericarditis after receiving the second
dose and the benefit of vaccination to protect complications
related to COVID-19 infection, the Scientific Committee on
Vaccine Preventable Diseases and the Scientific Committee
on Emerging and Zoonotic Diseases under the Centre for
Health Protection of the Department of Health of Hong Kong
recommended adolescents between 12 and 17 years to receive
1 dose of the Comirnaty vaccine, instead of 2 doses, on 15
September 2021 [25]. Although our study provided the most
comprehensive epidemiology of myocarditis/pericarditis
following Comirnaty vaccination before the policy change,
ongoing observations on the incidence of myocarditis/per-
icarditis following the Comirnaty vaccination with 1-dose
Comirnaty vaccination as well as the rate of COVID-19 in-
fections among adolescents in Hong Kong shall be conducted
to provide real-world evidence on the risk and benefit of the
policy change.
This study has several strengths and limitations. All subjects
presented to the accident and emergency department or in the
outpatient clinics in the public system received comprehensive
reviews and investigations to rule out the possibility of myo-
carditis/pericarditis because of viral infection, and cMRI to
confirm subtle inflammation of the myocardium. However,
asymptomatic subjects and subjects with transient and subtle
symptoms of acute myocarditis/pericarditis, such as tachy-
cardia and mild chest discomfort, might not seek medical con-
sultation or have sought medical consultation in the private
sector which were not reported. Some patients had negative
MRI results because not all MRI suites in Hong Kong’s public
hospitals have the capability for T1 and T2 mapping to calculate
the extracellular volume, leading to lower sensitivities and un-
able to meet the 2018 Lake Louise Criteria for the diagnosis of
myocarditis. Furthermore, the incidence of acute myocarditis/
pericarditis following the COVID-19 vaccination remained
to be high, possibly attributed to increased awareness of pos-
sible acute myocarditis/pericarditis following vaccination with
COVID-19 vaccines compared with other jurisdictions, as well
as to the CARE program to capture AEFI. The high incidence
of acute myocarditis/pericarditis following Comirnaty vaccina-
tion among adolescents presented in this study is representable
as the HA receives majority of emergency admissions in Hong
Kong [4]. Finally, different criteria were likely used by clinicians
in generating a diagnostic code among the nonvaccinated in-
dividuals for the calculation of the background myocar-
ditis/pericarditis incidence as it was in a nonresearch setting.
8 • CID 2022:XX (XX XX) • Chua et al
Nevertheless, we have included myocarditis and pericarditis of
all causes, including idiopathic cases, for the calculation of the
background incidence.
Conclusion
Chinese adolescent males have a higher risk of acute myo-
carditis/pericarditis following vaccination with Comirnaty,
especially after the second dose. Medical professionals and re-
cipients of the Comirnaty vaccine should be vigilant regarding
the symptoms of acute myocarditis/pericarditis. Observations
on the incidence of myocarditis/pericarditis following the
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Comirnaty vaccination after changing to 1-dose vaccination
as well as the rate of COVID-19 infections among adolescents
shall be conducted.
Supplementary Data
Supplementary materials are available at Clinical Infectious Diseases online.
Consisting of data provided by the authors to benefit the reader, the posted
materials are not copyedited and are the sole responsibility of the authors,
so questions or comments should be addressed to the corresponding author.
Notes
Author contributions. P. I. and I. W. assessed and verified the data.
Concept and design. M. K., Y. L. L., I. W., and P I.
Acquisition of data. M. K., J. W., V. C., S. M. T., K. P. L.,Y. K. L., C. C. S.,
S. T., E. K., J. M., D. L., J. K. K. T., G. C. H. W. T., A. L., M. Y. N., C. K. C.,
and K. W. L.
Statistical analysis. C. C., W. W., E. C., T. T. M., and R. S.
Interpretation of data. All authors.
Literature review. H. W. T., D. L., M. L., K. Y. Y., W. H. L., K. L. C., and
G. C.
Drafting of the manuscript. G. C. and M. K.
Figures. R. S.
Critical revision of the manuscript for important intellectual content.
All authors.
Acknowledgments. The authors thank the Drug Office of the Department
of Health and the Hospital Authority for providing vaccination and clinical
data. They also thank Dr Bernard Chan, Wan-Mui Chan, Allen Wing-Ho
Chu, and Jonathan Daniel Ip for their technical support and administrative
assistance.
Financial support. Research grant from the Food and Health Bureau,
the Government of the Hong Kong Special Administrative Region (ref.
no. COVID19F01). I. C. K. W. reports support from Health and Medical
Research Fund of Hong Kong Government (Ref: COVID19F01 to The
University of Hong Kong).
Role of funding source. This is a regulatory pharmacovigilance study
initiated by the Department of Health (DH) and funded by the Food and
Health Bureau of the Government of the Hong Kong Special Administrative
Region. The corresponding author has full access to all the data in the study
and has final responsibility for the decision to submit for publication.
Potential conflict of interest. C. C. has received grants outside of the
submitted work from the Food and Health Bureau of the Hong Kong
Government, Hong Kong Research Grants Council, Hong Kong Innovation
and Technology Commission, Pfizer, IQVIA, and Amgen; and a personal fee
from Primevigilance Ltd. A. S. Y. L. received grants outside of the submitted
work from the Health and Medical Research Fund, Food and Health Bureau
of the Hong Kong Government Special Administrative Region. M. Y. N.
has received funding/education grants from the Food and Health Bureau of
the Hong Kong Government, Radiological Society of North America, GE,
Lode, Arterys, Bayer, Circle Cardiovascular Imaging and TeraRecon; hon-
oraria for education activities from Boehringer Ingelheim; reports the fol-
lowing leadership roles: Vice Chair of the Education Committee for Society
of Cardiovascular Magnetic Resonance and Member of the Corporate
Relations Committee for Society of Cardiovascular Computed Tomography.
G. C. F. C. is the CMO of Xellera and advisor of Pangenia. Y. L. L. received
Government funding for COVID-19 Vaccinations in Adolescents (COVA)
and is the Chairman of the Scientific Committee on Vaccine Preventable
Diseases, Centre for Health Protection, HKSAR. I. W. has received re-
search funding outside of the submitted work from Amgen, Bristol-Myers
Squibb, Pfizer, Janssen, Bayer, GSK, Novartis, Hong Kong Research Grants
Council, Hong Kong Health and Medical Research Fund, National Institute
for Health Research in England, European Commission, and National
Health and Medical Research Council in Australia (Research grants on
pharmacoepidemiology to The University of Hong Kong outside of the sub-
mitted work); consultancy fee for advising IQVIA on pharmacoepidemiology
studies outside of the submitted work; payment for expert testimony from
Appeal Court in Hong Kong (expert report on effects of cannabis outside of
the submitted work); and speaker fees from Janssen and Medicine in the pre-
vious 3 years; reports the following leadership roles: Member of Pharmacy
and Poisons Board (this is the regulatory agency in pharmaceutical product
licensing), Member of the Expert Committee on Clinical Events Assessment
Following COVID-19 Immunization (advise the Hong Kong Government
on safety of COVID-19 vaccines), and Member of the Advisory Panel on
COVID-19 Vaccines of the Hong Kong Government (advise the Hong Kong
Government on the emergency use of COVID-19 vaccines). He is also an
independent nonexecutive director of Jacobson Medical in Hong Kong (sal-
aried). P. I. has received grants outside of the submitted work from the Food
and Health Bureau of the Hong Kong Government, Hong Kong Research
Grants Council, and Hong Kong Jockey Club Charities Trust. M. T. Y. L.
reports receiving Honorarium for a talk on ADHD. W. K. C. N. reports per-
sonal honoraria for Guerbet online lecture on pediatric cardiac imaging;
holds 100 shares in Moderna stock, 50 shares in Biotech stock since April,
owned 100 shares in Pfizer stock from July 2020 to January 2021. All other
authors report no potential conflicts. All authors have submitted the ICMJE
Form for Disclosure of Potential Conflicts of Interest. Conflicts that the edi-
tors consider relevant to the content of the manuscript have been disclosed.
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